Abstract:
OBJECTIVES:The main objective of this novel study was to develop midazolam hydrochloride fast dissolving oral films (FDFs) using solvent casting method and to evaluate the characteristics of the optimum formulation through in vitro and in vivo analysis. The FDFs are new favorable solid dosage forms that deliver drugs rapidly to the blood circulation system and have great advantages in the emergent control of severe neuropathic attacks in children. METHODS:Midazolam nanosuspensions were prepared using the ultrasonic method and then incorporated in the hydroxypropyl methyl cellulose (HPMC)/pullulan polymeric matrix with other excipients like glycerol and cellulose nanofiber as a softener and a compatibilizer, respectively. The prepared films were evaluated for mechanical properties, morphology study, disintegration time, and dissolution time. RESULTS:SEM images of FDFs showed the uniform distribution of spherical nanoparticles in the polymeric matrix. A film with 36% HPMC, 64% pullulan, and 21% glycerin was selected as the optimum formulation by the Design Expert 7 software. The optimum film was stable for three months. CONCLUSION:The pharmacokinetic parameters of midazolam oral film in comparison to coarse midazolam suspension exhibited significant increase in AUC, Cmax, and a good decrease in Tmax. The overall results showed the enhanced in vivo orotransmucosal absorption of poorly water-soluble drugs via the insertion of drugs nanosuspension in buccal films.
journal_name
Curr Drug Delivjournal_title
Current drug deliveryauthors
Soroushnai A,Ganji F,Vasheghani-Farahani E,Mobedi Hdoi
10.2174/1567201815666180723115600subject
Has Abstractpub_date
2018-01-01 00:00:00pages
1294-1304issue
9eissn
1567-2018issn
1875-5704pii
CDD-EPUB-91881journal_volume
15pub_type
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